On May 19, 2022 The European Organisation for Research and Treatment of Cancer (EORTC) reported its continued partnership with Alliance Healthcare, one of the largest pharmaceutical wholesalers in Europe (Press release, EORTC, MAY 19, 2022, View Source [SID1234614861]). Specifically, the collaboration supports the organisation’s SPECTA platform, a pan-European translational research infrastructure for all tumour types including rare cancers.

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The EORTC SPECTA platform allows for the rapid implementation of new clinical trials and robust translational cancer research aimed at increasing our understanding of cancers in order to guide a more targeted clinical research and treat patients effectively.

Alliance Healthcare was previously owned by Walgreens Boots Alliance (WBA) until June 2021. Since then, Alliance Healthcare is a wholly owned subsidiary of AmerisourceBergen and the EORTC is delighted that its support and commitment to SPECTA is to continue under this new ownership. The fantastic support that Alliance Healthcare as part of WBA has provided over the past 10 years (since 2011) will persist to further reinforce and strengthen recognition of the SPECTA platform as the leading pan-European translational research infrastructure. The partnership with Alliance Healthcare under the umbrella of AmerisourceBergen will ensure the continuation of SPECTA’s work in personalised cancer medicine, helping guide patients’ treatments, but also advance our understanding of cancer biology to help treat more patients effectively.

Through the growth of SPECTA’s translational clinical research, it provides hope to thousands of patients. One patient with papillary thyroid cancer said that their "current treatment was defined after [their] inclusion in SPECTA" and after previous treatments didn’t work.

Treating oncologists also benefit from SPECTA. Pr. Jean-Yves Blay has said "the SPECTA study enables [the opportunity] to gain more understanding on the nature of the disease and to guide the treatment of many patients with rare cancer, which is quite unique."

Today, SPECTA’s ever-growing cancer clinical research platform includes 128 authorized research doctors in 17 countries. More than 1330 patients have participated in 3 clinical research projects with over 1200 individual result reports provided to patients and providing guidance for their treatment.

EORTC CEO, Dr Denis Lacombe commented "EORTC looks forward to continue working with Alliance Healthcare and AmerisourceBergen, pushing the boundaries of understanding cancer and furthering the standard of care for cancer patients in the European continent, through SPECTA."

Juan Guerra, SVP Managing Director at Alliance Healthcare said "I am extremely proud of the efforts of Alliance Healthcare colleagues Europe-wide over the last decade. The work the EORTC does, and advancements in cancer therapies and treatment SPECTA brings about, is critical in the fight against this disease. I am extremely happy that under our new AmerisourceBergen ownership we are continuing to help and support through a range of fund-raising initiatives and a donation from the AmerisourceBergen Foundation as together we aim to improve the health and wellbeing of patient populations."

On May 19, 2022 Alchemab Therapeutics, a biotechnology company focused on the discovery and development of naturally-occurring protective antibodies and immune repertoire-based patient stratification tools, reported the publication of research demonstrating the potential of AntiBERTa (Antibody-specific Bi-directional Encoder Representation and Transformers), a transformer neural network that reads the components of an antibody amino acid sequence, to deeply understand the structure and function of antibody sequences (Press release, Alchemab Therapeutics, MAY 19, 2022, View Source [SID1234614877]). The article, titled "Deciphering the language of antibodies using self-supervised learning" has been published online in the journal Patterns. AntiBERTa is a 12-layer transformer model that provides a contextualized numeric representation of antibody sequences and learns biologically relevant information.

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"AntiBERTa forms the basis of Alchemab’s machine learning platform, providing a pre-trained model which is primed for multiple downstream tasks relevant to antibody drug discovery," said Jake Galson, Ph.D., Head of Technology at Alchemab. "We have already demonstrated the utility of AntiBERTa for binding-site prediction, and this is helping us to better identify convergent antibodies associated with disease resilience. We are excited to further progress our research and leverage our expertise to develop pioneering ways of treating diseases in the field of immunotherapy."

The study found that the B cell receptor (BCR) sequence representations separate according to mutational load and the underlying BCR V gene segments used. Importantly, there is distinct partitioning of BCRs derived from naïve versus memory B cells, suggesting that functionally important information is captured by the model. Finally, the model recognized pairs of positions within the BCR sequence that form contacts in three-dimensional space. These data demonstrate that AntiBERTa learns various characteristics of the BCRs, such as B cell origin, activation level, immunogenicity, and structure.

Dr. Jane Osbourn, PhD, Co-founder and Chief Scientific Officer of Alchemab, commented: "Our AntiBERTa technology has the potential to transform our ability to understand antibody structure and function and will inform our understanding of antibody paratopes, or the amino acid sequences comprising the site at which antibodies bind to antigens. It will also enable Alchemab to continue to build its unbiased platform to identify novel oncology and neurodegenerative targets. Alchemab’s novel approach learns from nature and naturally optimized antibodies and works backwards to uncover the most important targets and pathways involved in disease modulation. This approach has been very successful, leading to the identification of several novel oncology and neurodegenerative disease drug targets."

On May 19, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and an emerging pre-clinical pipeline, reported that it will be presenting details on the trial design for the INBRX-109 Phase 2 potentially registration-enabling trial in conventional chondrosarcoma at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting to be held June 3rd through June 7th, 2022 in Chicago, Illinois (Press release, Inhibrx, MAY 19, 2022, View Source [SID1234614894]).

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Details on the poster presentation are shared below:

Title: A randomized, placebo-controlled phase 2 trial of INBRX-109 in unresectable or metastatic conventional chondrosarcoma
Track/Session: Sarcoma
Poster number:486a
Presenter: Sant P. Chawla, MD
Date & Time: Sunday, June 5, 2022 from 9 a.m. to 11 a.m. CST
Location: Exhibit Hall A

The poster will be available on-demand on the ASCO (Free ASCO Whitepaper) website for attendees beginning at 9:00 AM CST on Friday, June 3, 2022. Upon release at ASCO (Free ASCO Whitepaper), the scientific poster will be accessible through Inhibrx’s website at View Source

About Chondrosarcoma

Chondrosarcoma is an orphan bone cancer with approximately 2,800 new patients diagnosed annually in the United States and the European Union. There are currently no systemic therapies approved for the treatment of chondrosarcoma.

About INBRX-109

INBRX-109 is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 signaling.

In January 2021, the FDA granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma. Further, in December 2021, FDA granted Orphan Drug Designation to INBRX-109 for this indication.

In November 2021, Inhibrx provided updated results from its ongoing Phase 1 clinical trial evaluating the efficacy and safety of INBRX-109 in patients with conventional chondrosarcoma. Preliminary disease control was observed in 16 of the 18 evaluable patients (89%) measured by RECISTv1.1, with two of the 18 achieving partial responses (11%). Based on preliminary results of the ongoing Phase 1 trial, the median progression-free survival (PFS) is 7.4 months, and the median overall survival has not been reached. Three patients have exceeded 61 weeks on treatment with INBRX-109, with 77 weeks being the longest duration of stable disease observed to date.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, potentially registration-enabling Phase 2 trial of INBRX-109 in conventional chondrosarcoma. The trial will be conducted at approximately 51 sites within eight countries, with 30 of those sites in the United States.

On May 19 , 2022: Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) reported its consolidated financial results for the fourth quarter and full year ended March 31, 2022 (Press release, Dr Reddy’s, MAY 19, 2022, View Source [SID1234614845]). The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS). Commenting on the results, Co-Chairman & MD, G V Prasad said: "We delivered healthy growth in revenue, though the profits were impacted by impairment charges.

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In spite of multiple external challenges, our core businesses performed well driven by an increase in market share, some strong launches and productivity improvement. We will continue to focus on growing our core businesses, invest in future growth drivers, and work towards greater integration of Sustainability in our businesses." Revenue Analysis [Q4 and full year FY22] Global Generics (GG)  GG segment at Rs. 179.2 billion higher by 16% over FY21. This growth was driven by good performance across all our markets with strong growth in Emerging markets and India.

 Q4 revenue at Rs. 46.1 billion, YoY growth of 19% and QoQ growth of 4%. The YoY & QoQ growth was driven by growth across all our markets, however the QoQ growth was partially impacted due to a decline in revenues in India. North America  Revenues from North America Generics for the year at Rs. 74.9 billion, YoY growth of 6%. The growth was contributed by new launches and scale up of existing products, which was partially offset by price erosion.  Revenues for Q4 at Rs. 20.0 billion, YoY growth of 14% and QoQ growth of 7%. The YoY and QoQ growth were primarily on account of new product launches and volume traction in some of our products, partly offset by price erosion.

 During this quarter, we launched 3 new products – Vasopressin Injection, Nicotine Lozenges Cherry Flavour (OTC) and Clobetasol Shampoo in Canada and for full year we have launched 17 products.  During the year, we filed 7 new Abbreviated New Drug Applications (ANDAs) with the US Food and Drug Administration (USFDA). As of 31st March 2022, cumulatively 90 generic filings are pending for approval with the USFDA (87 ANDAs and 3 NDAs under 505(b)(2) route). Out of the pending 87 ANDAs, 44 are Para IVs, and we believe 24 have ‘First to File’ status. Europe  Revenues from Europe for the year at Rs. 16.6 billion. YoY growth of 8%, primarily on account of volume traction in base business and new product launches, which was partially offset by price erosion in some of our products.  Revenues for Q4 at Rs. 4.4 billion, YoY growth of 12% and QoQ growth of 10%. YoY and QoQ growth was primarily on account of new product launches, partly offset by price erosion in the base business. India  Revenues from India for the year at Rs. 42 billion. Year-on-year growth of 26% was primarily attributable to an increase in both sales volume and price of our existing products, along with additional revenues from the launch of new products.

The growth was also aided by covid product sales. During FY2022, we launched 20 new brands in India, including Sputnik-V vaccine for Covid-19.  Revenues for Q4 at Rs. 9.7 billion, YoY growth of 15% and QoQ decline of 6%. YoY growth primarily driven by volume traction in the base business, favorable price variance, new product launches, and non-core brand divestments while QoQ decline was majorly due to decline in volumes of some of our products.Emerging Markets  Revenues from Emerging Markets for the year at Rs. 45.7 billion, growth of 30% YoY.-Revenues from Russia for the year at Rs. 20.9 billion, YoY growth of 32%. This growth was driven by improved base business performance, launch of new products during the year and divestment of a few non-core brands.-Revenues from other CIS countries and Romania for the year at Rs. 8.3 billion, YoY growth of 11%. Growth was on account of new product launches, partly offset by lower volumes.-Revenues from Rest of World (RoW) territories for the year at Rs. 16.5 billion, YoY growth of 40%.

Growth primarily on account of new launches, volume traction in key products and sale of Covid products, partially impacted by adverse price variance in certain markets.  Revenues for the quarter are Rs. 12 billion, YoY growth of 36%, QoQ growth of 4%.-Revenues for Russia for Q4 at Rs. 6.9 billion, YoY growth of 70%, QoQ growth of 45%. The increase is majorly attributable to traction in volume of base business and income from divestment of a few non-core brands. However, the QoQ growth was partly impacted by adverse forex rates.-Revenues from other CIS countries and Romania for the quarter are Rs. 2.3 billion, YoY growth of 20%, QoQ decline of 4%. YoY growth was primarily due to launch of new products and price benefits in some of our markets. The QoQ decline was on account of lower volume traction in some of our markets and adverse forex rates.-Revenues from Rest of World (RoW) territories for Q4 are Rs. 2.9 billion, YoY decline of 1% and QoQ decline of 35%. The QoQ decline is primarily due to higher base of previous quarter which includes sale of covid related products, lower volumes in some of our products and adverse price variance in some of our markets, which was offset partially by new product launches. Pharmaceutical Services and Active Ingredients (PSAI) 

Revenues from PSAI at Rs. 30.7 billion. YoY decline of 4%. The decline was majorly on account of price erosion in some of our products.  Revenues for Q4 at Rs. 7.6 billion, YoY decline of 5% and QoQ growth of 4%. YoY decline was primarily due to lower volumes and price erosion while the QoQ growth was driven by new product sales.  During the year, we have filed 10 DMFs in the US, of which 3 DMFs were filed in Q4FY22. Proprietary Products (PP) & Others  Revenues from PP & others for the year at Rs. 4.5 billion, YoY growth of 34%. The growth is attributable to recognition of a license fee associated with the sale of our U.S. and Canada territory rights for ELYXYB (celecoxib oral solution) 25 mg/ml, to BioDelivery Sciences International, Inc during Q2 FY22.

 Revenues for Q4 at Rs. 693 million.Income Statement Highlights:  Gross profit margin for the year at 53.1%, a decrease of ~120 bps over previous year. The decrease was driven by pricing pressure in the North America & Europe, lower export benefits, and an increase in the inventory provisions. This was partially offset by productivity benefits. Gross profit margin for GG and PSAI business segments are at 57.6% and 22.2% respectively. Gross profit margin for the Q4 at 52.9% (GG: 58.2%, PSAI: 18.4%). Gross margin declined by ~80 bps YoY and by ~90 bps QoQ. The decline was primarily due to price erosion, an increase in the inventory provisions, which was partly offset by income from divestment of non-core brands.  Selling, general & administrative (SG&A) expenses for FY22 at Rs. 62.1 billion, an increase of 14% on a YoY basis. This increase was primarily due to annual increments, investments in brands and digitalization, and royalty paid on sales. SG&A expenses for Q4 at Rs. 15.7 billion, YoY increase of 9% and QoQ increase of 2%. The increase is mainly due to provision made of Rs. 1.0 billion pertaining to litigation with Texas state, US. SG&A as a % to sales for the full year remained largely in line with FY21.  Impairment charge at Rs. 7.6 billion in FY22. This is majorly due to product impairment of PPC-06 (Tepilamide Fumarate Extended Release Tablets) of Rs. 4.3 billion on account of its decrease in market potential and impairment of Shreveport plant assets and Goodwill of Rs. 3.1 billion which were taken considering the triggers which occurred during the year.  Research & development (R&D) expenses in FY22 at Rs. 17.5 billion. As % to Revenues – FY22: 8.2% | FY21: 8.7%. R&D expenses for Q4 at Rs. 4.3 billion, as % to revenues stood at 8.0%. Our focus continues on building a global pipeline of new products across our markets.

 Other operating income for the year at Rs. 2.8 billion compared to Rs. 1 billion in FY21. The increase was on account of recognition of income towards sale of our rights relating to anti-cancer agent E7777 (denileukin diftitox) to Citius Pharmaceuticals in Q2 FY22. Other operating income in Q4 is Rs. 0.3 bn.  Net Finance income for the year at Rs. 2.1 billion compared to Rs. 1.7 billion in FY21. The increase is primarily on account of higher foreign exchange gain in current year as compared to FY21. Net finance income in Q4 is Rs. 0.9 billion.  Profit before Tax for the year at Rs. 32.3 billion, growth of 22%. Profit before Tax for Q4 is Rs. 2.5 bn.  Profit after Tax for the year at Rs. 23.6 billion and for Q4 at Rs. 0.9 billion. The effective tax rate for the year has been 27.0% as compared to 34.7% in FY21 and that for the quarter has been at 64.8% as compared to 41.2% in Q4 FY21. The ETR was higher on account of lower Profit before Tax, due to the impairment charge taken.  Diluted earnings per share for the year is Rs. 141.7. Diluted earnings per share for Q4 is Rs. 5.3.

Other Highlights:  EBITDA for FY22 at Rs. 51.4 billion and the EBITDA margin is 24.0%. EBITDA for Q4 FY22 is at 13.0 billion and the EBITDA margin in 23.9%.  Capital expenditure for FY22 is at Rs. 14.7 billion. Capital expenditure for Q4 FY22 is at Rs. 3.7 billion.  Free cash-flow for FY22 is at Rs. 11.6 billion and for Q4 it is at Rs. 4.8 billion.  Net cash surplus for the company is at Rs. 15.5 billion as on March 31, 2022. Consequently, net debt to equity ratio is (0.08).  The Board has recommended payment of a dividend of Rs. 30/-per equity share of face value Rs. 5/-each (600% of face value) for the year ended March 31, 2022 subject to approval of members.

Earnings Call Details (05:30 pm IST, 08:00 am EDT, May 19, 2022) The management of the Company will host an earnings call to discuss the Company’s financial performance and answer any questions from the participants.

On May 19, 2022 Inceptor Bio, a biotechnology company advancing cell therapies for difficult-to-treat cancers, reported the closing of a $37 million Series A financing led by Kineticos Ventures (Press release, Inceptor Bio, MAY 19, 2022, View Source [SID1234614862]).

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Proceeds from the Series A financing will be used to advance Inceptor Bio’s CAR-T lead program to a Phase I clinical trial and continue development of its CAR-M and CAR-NK platforms. Additionally, proceeds will support completion of Inceptor Bio’s Advanced Manufacturing Platform (AMP+) facility, a 29,000 square foot, state-of-the-art cell and gene therapy GMP manufacturing site located in Gainesville, Florida.

Inceptor Bio’s CAR-T, CAR-M, and CAR-NK platforms are at the center of a diversified portfolio of cell therapies focused on novel mechanisms that enhance cell performance in the tumor microenvironment. Novel technologies include a co-stimulatory domain M83, proprietary TMax manufacturing process, the K62 platform, which increases the phagocytic capabilities of macrophages and supports a M1 anti-tumor phenotype, and a differentiated iPSC technology.

"We are grateful for the continued support of Kineticos Ventures and our life sciences investors," said Shailesh Maingi, Founder and CEO of Inceptor Bio. "We have a simple strategy at Inceptor Bio. We’re advancing novel CAR-T, CAR-M and CAR-NK platforms into the clinic, securing our supply through AMP+, and building a leading team of scientists and engineers in order to improve treatment options for patients with difficult-to-cancers."

"This Series A funding allows us to focus on advancing our lead CAR-T program into the clinic while continuing to advance our other exciting cell therapy platforms," said Mike Nicholson, Ph.D., President and Chief Operating Officer of Inceptor Bio. "Our programs address serious challenges in the cell therapy arena, and fully realizing the potential of these therapies requires significant capital. We are grateful for the support of this incredible group of investors."

"Investing in early life sciences companies with promising pipelines like Inceptor Bio is at the heart of what we do," said Frank Lis, President of Kineticos Ventures. "With an expert team and a scalable manufacturing facility, Inceptor Bio is well positioned to advance next-generation cell therapy technologies to address difficult-to-treat cancers."